Imagine this: it’s a typical morning, you’re completing your regular check-ins with the manufacturing plant manager when you suddenly get a Notice of Inspection (FDA Form 482) from an investigator. The investigator is waiting patiently in your front office. Immediately the panic starts to set in, and you think: are we ready?

One of the hardest things for a worksite to do is prepare for an FDA inspection and audit simply because there’s no warning. Inspectors can show up anytime they like, with little warning. If you’re not prepared, this can result in huge compliance issues and red flags for your operation. This means you need to always be on alert and ready to be inspected at any time. That old Boy Scout motto ‘Be Prepared’ is especially apt.

But there’s a second possible scenario here: imagine you get the notice of inspection and a wave of confidence comes over you. You think finally, my hours of hard work and preparation have paid off – we’re ready.

To help you turn that second scenario into your new normal, here are some tips from our EHSQ experts to keep in mind when preparing for your next inspection.

The Process: What to Expect During an FDA Audit

An investigator will examine your production process, look at your records, collect samples, ask for documentation, and more depending on your operations. At the end of the audit, they will discuss with you and your management any significant red flags from the inspection, including observations and potential concerns. The inspector will provide you and management with a written report and list of Inspectional Observations (FDA Form 483) which outlines their observations, including any objectionable conditions or issues. This report will then act as a guide for you and your management team to implement corrective and preventive actions (CAPAs). 

How to Prepare: Your Audit-Proof Checklist

Gather Your Co-Scouts


Incidents and Injuries

Dress Rehearsal

The Secret Weapon

Let’s walk through a case study that looks at how an EHSQ software solution can help food and beverage companies ace an FDA audit.

Case Study: How EHSQ Software helped a Food Manufacturer Improve Risk Management

Food and beverage manufacturers need to consistently monitor quality across their entire facility in order to be compliant with stringent regulations. Tracking non-conformances, equipment calibration, and documentation all need to be properly managed in order to meet these requirements.

A food manufacturing company was working through regulatory checks, including a check of the FDA requirement for disease control. An employee suddenly tested positive for Hepatitis A during a routine check. Luckily, the manufacturer had implemented an EHSQ software system that immediately flagged the positive test.

The Automated Process Kicked-In:

Through automation, the organization was able to quickly identify and proactively manage a critical health risk and quarantine the product before any of it left the facility. By being able to trace their sampling efforts and leverage automation, they avoided a huge product recall that would have resulted in a significant impact to customer confidence, product sales, and brand reputation.

The automated workflow that was set-up within the EHSQ application worked perfectly. It alerted the correct people and provided them with actionable items to resolve the issues quickly. There was no need to wait for someone to react.

The following week, an FDA inspector came onsite to investigate the manufacturing plant. The EHS Manager and onsite Operations Officer were ready to demonstrate their response to the above event quickly and effectively. They also walked the inspector through all their original documentation, follow-up reports, and then shared how their system is handling future employee illness cases.

Concluding Remarks

Agency audits don’t have to be overwhelming if you’ve implemented and leveraged the correct people, processes, and technology. If done correctly, you’ll be surprised at how relaxed you are during your next audit.

To learn more about how to modernize your processes and reduce risk across your operations, download our eBook, Create the Facility of Tomorrow, Today.